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Thirst in Intensive Care Unit (ICU) PracticeTHIRSTNCT05473351

Thirst in the Intensive Care Unit, Recognition, Sensitivity and Type

An observational study of Thirst in Intensive Care Unit (ICU) Practice, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Thirst is a perception that provokes the desire to drink liquids. It is a multidimensional symptom that is described in terms of intensity and distress and is associated with dry mouth, called xerostomia. Thirst is poorly recognized in intensive care unit practice. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Questionnaire
How many people
203 participants
Where
3 sitesFrance
Study dates
29 Dec 2022to 29 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients on invasive mechanical ventilation, admitted to one of the participating centers

Who may be able to join

  • Patient 18 years of age and older
  • Patients undergoing invasive mechanical ventilation for at least 24 hours at one of the participating centers
  • No objection to participation in the study

Who cannot join

  • Patients unable to communicate verbally and reliably self-report thirst:
  • Richmond Agitation-Sedation Scale (RASS) < -2 or > +2,
  • delirium according to the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) (if confusion is suspected)
  • severe cognitive impairment or severe mental illness
  • non-French speaking patients
  • severe hearing loss.
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  • Pregnant women
  • Adults under legal protection
  • Not affiliated to a social security system or not benefiting from such a system

Trial locations and contacts

3 sites in 1 country.

France3 sites
  • Service de médecine intensive et réanimation, hôpital Avicenne

    Bobigny, 93000

  • Service de médecine intensive et réanimation, hôpital Saint-Louis

    Paris, 75010

  • Service de medecine intensive et réanimation, hôpital Pitié Salpêtrière

    Paris, 75013

Other trials in France

About this study

Thirst is a perception that provokes the desire to drink liquids. It is a multidimensional symptom that is described in terms of intensity and distress and is associated with dry mouth, called xerostomia.

Thirst is poorly recognized in intensive care unit practice. Yet, research has shown that it is one of the most prevalent, most intense, and least well treated symptoms in intensive care patients. Thirst and dry mouth are associated with physical discomfort in the ICU. However, thirst often goes unnoticed and untreated.

Read more

In this context, The investigators aim to conduct a prospective observational study in mechanically ventilated patients able to communicate to better understand the prevalence, intensity, mechanisms and prognostic value of thirst as well as dry mouth sensation.

Primary objective: to assess thirst in mechanically ventilated patients. Primary endpoint: visual analog thirst scale from 0 mm (no thirst) to 100 mm (maximal thirst)

  1. Patient 18 years of age and older
  2. Patients undergoing invasive mechanical ventilation for at least 24 hours at one of the participating centers
  3. No objection to participation in the study During the study period, patients from 3 resuscitation sites are systematically screened for inclusion in the study on a daily basis, between 9:00 am and 12:00 pm.

Subjects meeting the inclusion and non-inclusion criteria (with the exception of the delirium test) will be informed of the study by the principal investigator or any other investigator trained and declared in the research. The oral information will be completed by the delivery of an information note. Patients who wish to participate in the study will be given up to 24 hours to consider their decision.

If the patient agrees to participate in the study, his or her non-opposition is collected by the investigator on a dedicated form in duplicate. One copy will be given to the patient, and the other will be kept in the department with the research documents.

In case of suspected confusion, a delirium screening test (CAM-ICU) will be performed to verify the patient's eligibility. If the test confirms the presence of confusion, the patient will be excluded from the study.

The information and the collection of the non-opposition will be notified in the patient's medical file.

Following their inclusion, patients are assessed only once during their stay in the ICU: the day of inclusion.

Once enrolled, patients are asked to rate the intensity of thirst by placing a cursor on a 100 mm visual analog scale (VAS) bounded on the left by "not thirsty" and on the right by "intolerably thirsty".

If a patient understands the principle of the assessment but is unable to move the VAS cursor himself, the observer assists the patient by holding the scale and supporting the patient's forearm. If the subject is unable to move his or her arms (as in some cases of severe neuromuscular impairment), observers are allowed to manipulate the VAS slider following the patient's instructions. However, this is not recommended and should be avoided whenever possible. The slider should never be adjusted directly or solely by the investigator.

The visual analog scales for dry mouth, anxiety, pain and dyspnea will be performed as part of the protocol after the thirst assessment.

The oral status, the search for edema or skin folds and the Revised Oral Assessment Guide (ROAG) score for intubated patients will also be performed at the same time.

An average of 20 minutes is necessary to perform all these procedures.

Read the detailed description

Thirst was reported in 70% of symptom assessments of intensive care patients. Thirst is a major source of physical discomfort. This should make it a concern for clinicians and ICU nurses whose mission is to alleviate symptoms in addition to treating pathology.

Balancing extracellular and intracellular volume is a goal in the poorly communicating patient with no spontaneous access to water. Thirst may exist, persist, reappear, or increase again after the institution of water intake; it may reveal changes in the intra/extra sector or inappropriate intakes. Thirst could therefore be useful as a clinical management tool. However, it has not been studied to any great extent in mechanically ventilated patients.

Neglecting thirst in these circumstances is bound to cause suffering. This neglect may also offset the physiological benefits in terms of clinical outcomes. It could also have a negative impact at a distance through negative memories. Nevertheless, thirst is not routinely assessed in ICU patients, except after extubation when the patient has access to spontaneous hydration.

Mechanically ventilated patients have multiple causes of thirst and dry mouth and at the same time have difficulty communicating and limited access to water. It is essential to study thirst in this population. In particular, determining the prevalence of thirst in this population would raise awareness of its screening. Finally, understanding the main mechanisms involved in thirst in patients undergoing invasive mechanical ventilation would allow the development of therapeutic solutions to minimize it.

In this context, the investigators wish to conduct a prospective observational study in mechanically ventilated patients able to communicate in order to better understand the prevalence, intensity, mechanisms and prognostic value of thirst as well as the sensation of dry mouth. They will also focus on the relationship of thirst with dyspnea, anxiety and pain.

Description of the study population and rationale for its selection The management of thirst is usually ensured by free access to water and balancing the patient's extracellular volume.

In the mechanically ventilated patient, this management is made more difficult by many factors: lack of free access to water, difficulty in communication, sensation of dry mouth induced by the mechanical ventilation device.

The population studied corresponds to patients under invasive mechanical ventilation in three intensive care units of university hospitals:

Pitié Salpêtrière intensive care medicine unit, Avicenne hospital intensive care medicine unit, and Saint-Louis hospital intensive care medicine unit.

Justification of the duration of the research The objective would be to include 200 patients at a rate of approximately 66 patients per service.

Eligibility criteria Recruitment will consist in considering any patient under mechanical ventilation and communicating as potentially eligible, provided that they meet the inclusion/non-inclusion criteria.

Conduct of the research During the study period, patients from the 3 resuscitation sites are systematically screened for inclusion in the study on a daily basis, between 9:00 am and 12:00 pm.

Subjects meeting the inclusion and non-inclusion criteria will be informed of the study by the principal investigator or any other investigator trained and declared in the research. The oral information will be supplemented by an information note. Patients who wish to participate in the study will be given up to 24 hours to consider their decision.

If the patient agrees to participate in the study, his or her non-opposition is collected by the investigator on a dedicated form in duplicate. One copy will be given to the patient, and the other will be kept in the department with the research documents.

In case of suspected confusion, a delirium screening test (CAM-ICU) will be performed to verify the patient's eligibility. If the test confirms the presence of confusion, the patient will be excluded from the study.

The information and the collection of the non-opposition will be notified in the patient's medical file.

Once recruited, patients are asked to rate the intensity of thirst by placing a cursor on a 100 mm visual analog scale (VAS) bounded on the left by "not thirsty" and on the right by "intolerably thirsty".

If a patient understands the principle of the assessment but is unable to move the VAS cursor himself, the observer assists the patient by holding the scale and supporting the patient's forearm. If the subject is unable to move his or her arms (as in some cases of severe neuromuscular impairment), the observers are allowed to manipulate the VAS slider by following the patient's instructions. However, this is not recommended and should be avoided whenever possible. The slider should never be adjusted directly or solely by the investigator.

Visual analog scales for dry mouth, anxiety, pain, and dyspnea will be performed as part of the protocol after the thirst assessment. The oral status, the search for edema or skin folds and the Revised Oral Assessment Guide (ROAG) score for intubated patients will also be performed at the same time.

Follow-up of the population The included patients are evaluated only once during their stay in the ICU: the day of inclusion. The duration of their participation is estimated at 20 minutes.

Conduct in the presence of thirst in the patient In the event that the patient is thirsty, the investigator will immediately inform the patient's physician.

Being tested
Questionnaire
Keywords
Thirst, Intensive care unit,, Cohort

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

    Visual Analogic Scale

Study groups in NCT05473351
Study groupRoleWhat they receive
ThirstPatients undergoing invasive mechanical ventilation for at least 24 hours in one of the participating centers
Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. :Assessment of thirst in mechanically ventilated patients.

    visual analog thirst scale from 0 mm (no thirst) to 100 mm (maximum thirst)

    Measured: Through study completion, an average of 1 year

Secondary outcomes (6)
  1. Evaluation of the association between thirst and dry mouth in mechanically ventilated patients.

    Visual analog scale of dry mouth

    Measured: Through study completion, an average of 1 year

  2. Evaluation of the association between thirst and oral status in mechanically ventilated patients.

    Oral status: Oral Health Assessment Tool

    Measured: Through study completion, an average of 1 year

  3. valuation of the association between thirst and extracellular volume in ventilated patients

    Physical examination oriented towards the evaluation of extracellular and intracellular volume: presence of edema of the lower limbs or lumbar region, presence of a skin fold

    Measured: Through study completion, an average of 1 year

  4. Evaluation of the association between thirst and anxiety in the mechanically ventilated patient.

    Visual Anxiety Scale

    Measured: Through study completion, an average of 1 year

  5. Evaluation of the association between thirst and pain in mechanically ventilated patients.

    Visual Analogue Pain Scale measures pain intensity. It consists of a 10 numerical values, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')

    Measured: Through study completion, an average of 1 year

  6. Evaluation of the association between thirst and dyspnea in mechanically ventilated patients.ventilated patients.

    Visual analog scale of dyspnea measures dyspnea severity. It consists of a 10 numerical values, with two end points representing 0 ('absence of dyspnea') and 10 ('maximum dyspnea')

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2022
  2. Study start29 Dec 2022
  3. Primary completion29 Oct 2024
  4. Study completion29 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05473351
Sponsor's protocol ID
APHP220789
Acronym
THIRST
Status last verified
Jul 2025
First submitted
12 Jul 2022
Last updated
14 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

Questions about this trial

What is this clinical trial studying?

An observational study of Thirst in Intensive Care Unit (ICU) Practice, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

:Assessment of thirst in mechanically ventilated patients. (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.

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